Prognostic and predictive markers of response to treatment in patients with locally advanced unresectable and metastatic pancreatic adenocarcinoma treated with gemcitabine/nab-paclitaxel: Results of a retrospective analysis.

BACKGROUND: Recent studies support the use of gemcitabine and nab-paclitaxel in adults with locally advanced unresectable or metastatic pancreatic adenocarcinoma although insufficient data are available on prognostic and predictive markers of response to treatment. OBJECTIVE: The objective of this study is to identify treatment response markers in patients with locally advanced unresectable or metastatic pancreatic adenocarcinoma. MATERIALS AND METHODS: This is an observational, retrospective, and multicenter study. Sociodemographic, clinical, and therapeutic data were collected. Cox regression models were applied to determine associations. RESULTS: In total, 39 patients were included; 23.1% presented locally advanced pancreatic cancer and 76.9% metastatic disease. They received a mean of 6 ± 3 treatment cycles; 59% required dose reduction, 59% treatment delay, and 20.5% switched to a biweekly regimen. The overall response rate was 23% and the disease control rate was 81%. Median progression-free survival was 9 months and median overall survival (OS) was 15 months. A higher neutrophil/lymphocyte ratio (NLR) was significantly associated with lower OS. We reported Grades 1-4 nonhematological and hematological toxicities. CONCLUSION: NLR is a useful prognostic factor for OS in patients with locally advanced unresectable or metastatic pancreatic adenocarcinoma treated with gemcitabine and nab-paclitaxel. Moreover, we suggest that a biweekly regimen is an option for certain groups of patients.

Phase II trial of erlotinib plus capecitabine as first-line treatment for metastatic pancreatic cancer (XELTA study).

AIM: To evaluate the efficacy and safety of erlotinib plus capecitabine for metastatic pancreatic cancer. PATIENTS AND METHODS: This was a multicenter, uncontrolled, phase II trial. Patients with untreated metastatic pancreatic cancer received oral capecitabine at 1,000 mg/m(2) twice daily on days 1-14, of a 21-day treatment cycle; and oral erlotinib at 150 mg daily. RESULTS: Thirty-two patients were enrolled. The overall response rate (ORR) was 6%, with a median time to treatment failure of 2.1 months. The median follow-up was 7.6 months. The median progression-free survival was 2.1 months and median overall survival was 4.3 months. The one-year survival rate was 22%. Major grade 1 and 2 non-hematological toxicities were skin rash (34%), asthenia (31%) and diarrhea (31%). Grade 3 hematological toxicity was <13%. No grade 4 toxicities were detected. None of the patients died due to treatment toxicity. CONCLUSION: The combination of capecitabine with erlotinib is an active regimen with a favorable safety profile for patients with metastatic pancreatic cancer.